Mon-a-Therm
Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respective owners.
115manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 36 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Famidoc Technology Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| 510(k) | K895875 |
| Record published | 2023-05-29 |
| Record revised | 2026-05-13 (version 13) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 158 °F; Storage environment atmospheric pressure 12 to 106 KiloPascal; Storage environment humidity 15 to 95 % RH |
| Packaging | Case of 40, pack_or_inner_pack of 50, case of 2 |
| Sizes | Length 10 to 16 ft; catheter gauge 9 to 12 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 502-0401A | Length 16 ft | In distribution |
| 502-0400A | Length 16 ft | In distribution |
| 502-0400A | Length 16 ft | In distribution |
| 90044 | Catheter Gauge 12 Fr | In distribution |
| 90058 | In distribution | |
| 502-0415A | Length 10 ft | In distribution |
| 502-0405A | Length 16 ft | In distribution |
| 502-0415A | Length 10 ft | In distribution |
| 502-0411A | Length 10 ft | In distribution |
| 90044 | Catheter Gauge 12 Fr | In distribution |
| 502-0410A | Length 10 ft | In distribution |
| 502-0411A | Length 10 ft | In distribution |
| 502-0410A | Length 10 ft | In distribution |
| 90045 | In distribution | |
| 502-0401A | Length 16 ft | In distribution |
| 502-0405A | Length 16 ft | In distribution |
| 90045 | In distribution | |
| 90050 | Catheter Gauge 9 Fr | In distribution |
| 90050 | Catheter Gauge 9 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 434 |
| Safety 1st | Dorel Juvenile Group, Inc. | 180 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Diagnostix™ | American Diagnostic Corp. | 61 |
| DeRoyal | Deroyal Industries, Inc. | 58 |
| Braun | KAZ USA, Inc. | 53 |
| Exergen Temporal Scanner | Exergen Corporation | 50 |
| Level 1 | ICU Medical, Inc | 48 |
| Famidoc | Famidoc Technology Co., Ltd. | 47 |
| Adtemp™ | American Diagnostic Corp. | 35 |
| TempTraq | Blue Spark Technologies, Inc. | 35 |
| Medline | Medline Industries, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2026-04-23 | Class II | Under Investigation by firm | Temperature probe devices lack FDA clearance. | 1775 units |
| Covidien | UDI-DI | 2026-04-23 | Class II | Under Investigation by firm | Temperature probe devices lack FDA clearance. | 128,900 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.